Brand Name
Vinorelbine
View Brand InformationFDA approval date: September 15, 2014
Classification: Vinca Alkaloid
Form: Injection
What is Vinorelbine?
Vinorelbine Injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine Injection is a vinca alkaloid indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer As a single agent for first-line treatment of patients with metastatic NSCLC
Approved To Treat
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Brand Information
Vinorelbine (Vinorelbine)
WARNING: MYELOSUPPRESSION
- Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see
- Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see
1INDICATIONS AND USAGE
Vinorelbine injection is indicated:
- In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
- As a single agent for the treatment of patients with metastatic NSCLC
2DOSAGE FORMS AND STRENGTHS
Injection: 1 mL (10 mg/mL) and 5 mL (50 mg/ 5 mL) clear colorless to pale yellow solution in single-dose vial
3CONTRAINDICATIONS
None
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Myelosuppression
- Hepatic Toxicity
- Severe Constipation and Bowel Obstruction
- Extravasation and Tissue Injury
- Neurologic Toxicity
- Pulmonary Toxicity and Respiratory Failure
4.1Clinical Trials Experience
Because clinical trials are conducted under varying designs and in different patient populations, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial and may not reflect the rates actually observed in clinical practice.
Single Agent
The data below reflect exposure to vinorelbine as a single agent administered at a dose of 30 mg/m
Selected adverse reactions reported in these studies are provided in Tables 1 and 2. The most common adverse reactions (≥ 20%) of single agent vinorelbine were leukopenia, neutropenia, anemia, increased aspartate aminotransferase (AST), nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy. The most common (≥ 5%) Grade 3 or 4 adverse reactions were neutropenia, leukopenia, anemia, increased total bilirubin, increased AST, injection site reaction and asthenia.
Approximately 49% of patients with NSCLC who were treated with vinorelbine experienced at least one dose reduction due to an adverse reaction.
Thirteen percent of patients discontinued vinorelbine due to adverse reactions. The most frequent adverse reactions leading to vinorelbine discontinuation were asthenia, dyspnea, nausea, constipation, anorexia, myasthenia and fever.
Myelosuppression: In clinical trials, Grade 3 to 4 neutropenia, anemia and thrombocytopenia occurred in 69%, 9% and 1%, respectively of patients receiving single agent vinorelbine. Neutropenia is the major dose-limiting toxicity.
Neurotoxicity: Neurotoxicity was most commonly manifested as constipation, paresthesia, hyperesthesia and hyporeflexia. Grade 3 and 4 neuropathy was observed in 1% of the patients receiving single agent vinorelbine.
Injection Site Reactions: Injection site reactions, including erythema, pain at injection site and vein discoloration, occurred in approximately one third of patients; 5% were severe. Phlebitis (chemical phlebitis) along the vein proximal to the site of injection was reported in 10% of patients.
Cardiovascular Toxicity: Chest pain occurred in 5% of patients; myocardial infarction occurred in < 0.1% of patients.
Pulmonary Toxicity and Respiratory Failure: Dyspnea (shortness of breath) was reported in 3% of patients; it was severe in 2%. Interstitial pulmonary changes were documented.
Other: Hemorrhagic cystitis and the syndrome of inappropriate ADH secretion were each reported in < 1% of patients.
In Combination with Cisplatin
Table 3 presents the incidence of selected adverse reactions, occurring in ≥ 10% of vinorelbine treated patients reported in a randomized trial comparing the combination of vinorelbine 25 mg/m
Patients randomized to vinorelbine plus cisplatin received a median of 3 cycles of treatment and those randomized to cisplatin alone received a median of 2 cycles of treatment. The incidence of Grade 3 and 4 neutropenia was significantly higher in the vinorelbine plus cisplatin arm (82%) compared to the cisplatin alone arm (5%).
Thirty-five percent of the eligible patients in the combination arm required treatment discontinuation due to an adverse reaction compared to 19% in the cisplatin alone arm.
Four patients in the vinorelbine plus cisplatin arm died of neutropenic sepsis. Seven additional deaths were reported in the combination arm: 2 from cardiac ischemia, 1 cerebrovascular accident, 1 multisystem failure due to an overdose of vinorelbine, and 3 from febrile neutropenia.
Table 4 presents the incidence of selected adverse reactions, occurring in ≥ 10% of vinorelbine treated patients reported in a randomized trial of vinorelbine plus cisplatin, vindesine plus cisplatin and vinorelbine as a single agent in patients with stage III or IV NSCLC who had not received prior chemotherapy. A total of 604 patients received either vinorelbine 30 mg/m
Patients randomized to vinorelbine plus cisplatin received a median of 15 weeks of treatment, vindesine plus cisplatin 12 weeks and vinorelbine received 13 weeks. Grade 3 and 4 neutropenia was significantly greater in the vinorelbine plus cisplatin arm (78%) compared to vindesine plus cisplatin (48%) and vinorelbine as a single agent (53%). Neurotoxicity, including peripheral neuropathy and constipation, was reported in 44% (Grades 3 to 4, 7%) of the patients receiving vinorelbine plus cisplatin, 58% (Grades 3 to 4, 17%) of the patients receiving vindesine and cisplatin and 44% (Grades 3 to 4, 8.5%) of the patients receiving vinorelbine as a single agent.
Study discontinuation due to an adverse reaction was required in 27, 22 and 10% of the patients randomized to vinorelbine plus cisplatin, vindesine plus cisplatin and cisplatin alone arms, respectively.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of vinorelbine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections: pneumonia
Immune system disorders: anaphylactic reaction, pruritus, urticaria, angioedema
Nervous system disorders: loss of deep tendon reflexes, muscular weakness, gait disturbance, headache
Ear and labyrinth disorders: vestibular disorder, hearing impaired
Cardiac disorders: tachycardia
Respiratory disorders: pulmonary edema
Vascular disorders: pulmonary embolism, deep vein thrombosis, hypertension, hypotension, flushing, vasodilatation
Gastrointestinal disorders: mucosal inflammation, dysphagia, pancreatitis
Skin disorders: generalized cutaneous reactions (rash), palmar-plantar erythrodysesthesia syndrome
Musculoskeletal and connective tissue disorders: jaw pain, myalgia, arthralgia
General disorders and administration site conditions: injection site rash, urticaria, blistering, sloughing of skin
Injury, poisoning and procedural complications: radiation recall phenomenon, dermatitis, esophagitis
Laboratory abnormalities: electrolyte imbalance including hyponatremia
Other: tumor pain, back pain, abdominal pain
5OVERDOSAGE
There is no known antidote for overdoses of vinorelbine. Overdoses involving quantities up to 10 times the recommended dose (30 mg/m
6DESCRIPTION
Vinorelbine tartrate, USP is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, vinorelbine tartrate, USP is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure:
C
Vinorelbine Injection, USP is a sterile nonpyrogenic aqueous solution. Each milliliter of solution contains vinorelbine tartrate, USP equivalent to 10 mg vinorelbine in Water for Injection USP. The pH of Vinorelbine Injection, USP is approximately 3.5.
7REFERENCES
- OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
8HOW SUPPLIED/STORAGE AND HANDLING
Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in water for injection, USP containing 10 mg vinorelbine per mL. Vinorelbine Injection, USP is available in single-dose, clear glass vials with elastomeric stoppers and white (10 mg/mL) and lime green (50 mg/5 mL) caps, individually packaged in a carton in the following vial sizes:
Storage Conditions
Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton.
Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours.
Protect from light.
DO NOT FREEZE.
The vial stopper is not made with natural rubber latex.
Sterile, Nonpyrogenic, Preservative-free.
Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.
9PATIENT COUNSELING INFORMATION
Myelosuppression
Advise patients to contact a healthcare provider for new onset fever, or symptoms of infection
Constipation and Bowel Obstruction
Advise patients to follow a diet rich in fibers, drink fluids to stay well hydrated and use stool softeners to avoid constipation. Contact a health care provider for severe constipation, new onset abdominal pain, nausea and vomiting
Neurologic Toxicity
Advise patients to contact a health care provider for new onset or worsening of numbness, tingling, decrease sensation or muscle weakness
Pulmonary Toxicity
Advise patients to contact a healthcare provider for new onset or worsening of shortness of breath, cough, wheezing or other new pulmonary symptoms
Embryo-Fetal Toxicity
- Advise pregnant women of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with vinorelbine and for 6 months after the final dose
- Advise males with female partners of reproductive potential to use effective contraception during treatment with vinorelbine and for 3 months after the final dose
Lactation
Advise women not to breastfeed during treatment with vinorelbine and for 9 days after the final dose
Infertility
Advise males of reproductive potential that vinorelbine may impair fertility
Manufactured In Romania By:
Manufactured For:
Rev. D 5/2022
10PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Rx Only
NDC 45963-607-55
Vinorelbine Injection, USP
10 mg/mL
For Intravenous Use Only
Must Be Diluted Before Use
Discard Unused Portion
CAUTION: Cytotoxic Agent
Rx only
1 mL
Single-Dose Vial
